TEPADINA

Product NDC

53964-002

11-digit product format

539640002

Labeler code

53964

Product ID

53964-002_4f4fe702-275a-24c3-e054-00144ff88e88

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

THIOTEPA

Dosage form

INJECTION, POWDER, FOR SOLUTION

Route

INTRACAVITARY; INTRAVENOUS; INTRAVESICAL

Labeler

ADIENNE SA

Application

NDA208264

Marketing category

NDA

Marketing start

2017-01-26

Marketing end

0000-00-00

Substance

THIOTEPA

Active strength

100 mg/1

Pharmacologic classes

Alkylating Acti

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record